Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03215043 |
Other study ID # |
SaoPSU7 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2, 2017 |
Est. completion date |
February 28, 2018 |
Study information
Verified date |
August 2023 |
Source |
São Paulo State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and
insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on
the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be
evaluated. It is expected that metabolic parameters that constitute risk factors for diabetes
and associated chronic diseases are expected to be improved by supplementation with
eriocitrin
Description:
Volunteers will be invited to appear in a 12-hour fast to measure glucose levels, glycated
hemoglobin and to perform the glucose tolerance test, in addition to an individual interview
to confirm eligibility according to the inclusion and exclusion criteria. The collection of
blood and the glycemic curves will be carried out next to a Laboratory of Clinical Analyzes,
commercial, based in the city of Araraquara.
The sample number took into account variances on glycated hemoglobin with a type I error α =
0.05 and a type II error β = 0.2 (80% power) (Mohammad, 2015). The minimum sample size
considering an approximately 20% dropout rate, should have 20 individuals per group.
In order to ensure adequate nutrition for the nutritional and energetic needs of volunteers,
an individual food plan shall be prescribed, calculated according to the DRI equations. The
volunteer will be asked to complete the Food Record for three days at the 3rd, 5th, 7th, 9th
and 11th week. Data analysis of energy intake, macronutrients and micronutrients will be
performed through the DietBox® . The anthropometric measurements will be performed before the
intervention and in the 3rd, 5th, 7th, 9th and 11th week by Nutritionist. Four samples of
30mL of fasting blood each will be obtained before the intervention, in the 4th, 8th and 12th
week in the Laboratory of Clinical Analyzes. The blood will be centrifuged to obtain the
serum, which will be frozen at -80 ° C until subsequent biochemical analyzes.
Normality and homogeneity will be evaluated by Shapiro-Wilk test and Levine tests,
respectively. The T test will be used to compare baseline time between groups. The two-way
repeated-measures ANOVA will be used to compare changes within and between the eriocitrin and
control groups over the 12-week period. P significant at ≤ 0.05.